Part VII - Research Involving Special Subject Groups | KCTCS

Part VII

Research Involving Special Subject Groups

Children

In addition to the requirements specified elsewhere in this handbook, the following requirements are imposed on all research involving children. In the State of Kentucky, individuals under the age of eighteen are usually considered children.

Exempt Research

The categories of research that can be considered exempt from review are limited when children serve as subjects. Note particularly that the exemptions for research employing survey or interview procedures (Exemptions 2 and 3) do not apply to research involving children. Such projects must be submitted to the central HSRB. The exemption from review of research involving observation of public behavior (Exemption (b)2) applies only if the investigator does not participate in the activity being observed

Non-Exempt Research

Permission of Parents or Guardians

When children are subjects in research, the permission of the child's parents or guardian must be obtained prior to the child's participation. The requirements for obtaining parental permission are essentially the same as those for obtaining consent. In particular, all the elements of informed consent must be satisfied. The responsible project investigator must describe in the HSRB-1 form how parental permission will be obtained and must include a copy of the parent permission form, if one is to be used.

The permission of one parent is sufficient (a) if the research does not involve greater than minimal risk or (b) the research involves greater than minimal risk, but presents the prospect of direct benefit to the individual subjects. For research that involves greater than minimal risk and no prospect of direct benefit to the individual subjects, the permission of both parents is required, unless only one parent has legal responsibility for the custody of the child or the second parent is incompetent or not reasonably available. Special provisions must be met for children who are wards of the state to participate as subjects in research.

Assent of Children

In addition to parental permission, the investigator must obtain the assent of the children who are to be subjects in the research when those children are capable of providing assent. A child's desire not to participate in a given research project should be respected by the investigator. In determining whether children are capable of providing assent, the investigator and the HSRB should take into account the age, maturity, cognitive level, and psychological state of the children involved.

For research involving children who are capable of providing assent, the responsible project investigator must describe in the HSRB-1 form what will be taken as evidence of assent on the part of the children and how their assent will be obtained. The investigator must also describe what the children will be told about the research and how that information will be presented. The level of the information will vary as a function of the age and sophistication of the children involved. It can vary from a simple description of what the children will experience to the equivalent of the information that would be presented to an adult subject. All children capable of assent must be informed that they are free to withdraw from participation at any time.

For children who are not capable of providing assent, the investigator must take care that the subjects' rights are in no way abridged.

Assent of child subjects is not necessary when the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the individual children and is available only in the context of the research.

Waiver of Permission and Assent

Under certain circumstances, the HSRB may waive some or all of the parental permission and child assent requirements. In addition to the conditions for waiver described earlier in this handbook, the HSRB may waive permission of the parents or guardian if the following three conditions hold:

  1. the research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), and
  2. an appropriate mechanism is devised for protecting the children who participate in the research, and
  3. the waiver is not inconsistent with federal, state or local laws.

Prisoners

In addition to the requirements specified elsewhere in this handbook, the following requirements are imposed on all research involving prisoners.

Exemptions

All research involving prisoners must be reviewed by the HSRB. No research that involves prisoners as subjects is exempt from prior review by the HSRB.

Permitted Research Involving Prisoners

The only types of research involving prisoners that may be approved by the HSRB are the following:

  1. Study of the possible causes, effects, and processes of incarceration, and of criminal behavior, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects;
  2. Study of prisons as institutional structures or of prisoners as incarcerated persons, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects;
  3. Research on conditions particularly affecting prisoners as a class (for example, vaccine trials and other research on hepatitis which is much more prevalent in prisons than elsewhere; and research on social and psychological problems such as alcoholism, drug addiction, and sexual assaults) provided that the study may proceed only after the Secretary of Health and Human Services has consulted with appropriate experts, including experts in penology, medicine, and ethics and published notice in the Federal Register of her or his intent to approve such research; or
  4. Research on practices, both innovative and accepted, that have the intent and reasonable probability of improving the health or well-being of the subject. In cases in which those studies require the assignment of prisoners in a manner consistent with protocols approved by the HSRB to control groups that may not benefit from the research, the study may proceed only after the Secretary of Health and Human Services has consulted with appropriate experts, including experts in penology, medicine, and ethics and published notice in the Federal Register of her or his intent to approve such research.

Criteria for Approval

Research studies where prisoners are involved may only be approved if: 

  1. Any possible advantages accruing to the prisoner through her or his participation in the research, when compared to the general living conditions, medical care, quality of food, amenities, and opportunity for earnings in the prison, are not of such a magnitude that her or his ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired.
  2. The risks involved in the research are commensurate with risks that would be accepted by non-prisoner volunteers.
  3. Procedures for the selection of subjects within the prison are fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners. Unless the responsible principal investigator provides to the HSRB justification in writing for following some other procedures, control subjects must be selected randomly from the group of available prisoners who meet the characteristics needed for that particular research project.
  4. The information is presented in language that is understandable to the subject population.
  5. Adequate assurance exists that parole boards will not take into account a prisoner's participation in the research in making decisions regarding parole, and each prisoner is clearly informed in advance that participation in the research will have no effect on her or his parole; and
  6. Where the HSRB finds there may be a need for follow-up examination or care of participants after the end of their participation, adequate provision has been made for such examination or care, taking into account the varying lengths of individual prisoners' sentences and for informing participants of this fact.

Fetuses, Pregnant Women, Human Tissues

In addition to the requirements specified elsewhere in this handbook, the following requirements are imposed on all research involving fetuses, pregnant women, and human in vitro fertilization.

Exemptions

No research governed by HHS regulations directed toward pregnant women or fetuses is exempt from prior review by the HSRB.

General limitations

The only conditions under which research involving fetuses, pregnant women, and human in vitro fertilization are permitted are the following:

  1. appropriate studies on animals and nonpregnant individuals have been completed;
  2. except where the purpose of the research is to meet the health needs of the mother of the particular fetus, the risk to the fetus is minimal and, in all cases, is the least possible risk for achieving the objectives of the research;
  3. individuals engaged in the research will have no part in: (i) any decisions as to the timing, method, and procedures used to terminate the pregnancy and (ii) determining the viability of the fetus at the termination of the pregnancy;
  4. no procedural changes that may cause greater than minimal risk to the fetus or the pregnant woman will be introduced into the procedure for terminating the pregnancy solely in the interest of the research; and
  5. no inducements, monetary or otherwise, may be offered to terminate the pregnancy for purposes of the research.

Additional Criteria for HSRB Approval

In addition to applying other criteria for approval, the HSRB will determine the following:

  1. For research directed toward pregnant women as subjects
    1. No pregnant women may be involved as a subject in research unless
      • the purpose of the research is to meet the health needs of the mother, and the  fetus will be placed at risk only to the minimum extent necessary to meet such needs, or
      • the risk to the fetus is minimal.
    2. Research permitted under paragraph a. of this section may be conducted only if the mother and father are legally competent and have given their informed consent after having been fully informed regarding the possible impact on the fetus, except that the father's informed consent need not be secured if:
      • the purpose of the research is to meet the health needs of the mother, or
      • his identity or whereabouts cannot reasonably be ascertained, or
      • he is not reasonably available, or
      • the pregnancy resulted from rape.
  2. For research directed toward fetuses in utero as subjects
    1. No fetus in utero may be involved as a subject in any research unless:
      • the purpose of the research is to meet the health needs of the particular fetus and the fetus will be placed at risk only to the minimum extent necessary to meet such needs, or
      • the risk to the fetus imposed by the research is minimal and the purpose of the research is the development of important biomedical knowledge which cannot be obtained by other means.
    2. Such research may be conducted only if the mother and father are legally competent and have given their informed consent, except that the father's consent need not be secured if:
      • he is not reasonably available, or
      • his identity or whereabouts cannot reasonably be ascertained, or
      • the pregnancy resulted from rape.
  3. Research directed toward fetuses ex utero, including nonviable fetuses, as subjects
    1. Until it has been ascertained whether or not a fetus ex utero is viable, a fetus ex utero may not be involved as a subject in research unless:
      • there will be no added risk to the fetus resulting from the research and the purpose of the activity is the development of important biomedical knowledge that cannot be obtained by other means, or
      • the purpose of the research is to enhance the possibility of survival of the particular fetus to the point of viability.
    2. No nonviable fetus may be involved as a subject in research unless:
      • vital functions of the fetus will not be artificially maintained,
      • experimental research, which of itself would terminate the heartbeat or respiration of the fetus, will not be employed, and
      • the purpose of the research is the development of important biomedical knowledge that cannot be obtained by other means.
    3. In the event the fetus ex utero is found to be viable, it may be included as a subject in the research only to the extent permitted by the other requirements listed above.
    4. Such research may be conducted only if the mother and father are legally competent and have given their informed consent, except that the father's informed consent need not be secured if:
      • his identity or whereabouts cannot reasonably be ascertained, or
      • he is not reasonably available, or
      • the pregnancy resulted from rape.
  4. For research involving the dead fetus, fetal material, or the placenta. Activities involving the dead fetus, macerated fetal material, or cells, tissue, or organs excised from a dead fetus shall be conducted only in accordance with any applicable state or local laws regarding such research.

Modifications or Waiver of Specific Requirements

Upon the request of an applicant (with the approval of the Human Subjects Review Board), the Secretary of Health and Human Services may modify or waive specific requirements listed above with the approval of the Ethical Advisory Board after such opportunity for public comment as the Ethical Advisory Board considers appropriate in the particular instance. In making such decisions, the Secretary will consider whether the risks to the subject are so outweighed by the sum of the benefit to the subject and the importance of the knowledge to be gained as to warrant such modification or waiver and that such benefits cannot be gained except through a modification or waiver. Any such modifications or waivers will be published as notices in the Federal Register.

Research in Foreign Countries

Research that takes place in foreign countries must provide the same human subjects protection as research conducted in the United States. In addition, such research may raise special issues related to cultural differences. It is generally subject to special review processes at the federal level that can delay funding and/or the initiation of the research. As the current time, the Office for the Protection of Research Risks (OPRR) at NIH reviews all NIH-funded research involving human subjects outside the United States prior to funding (except research that meets one or more of the exemption categories, p. 9). In some cases, a determination may be made that the procedures in the foreign country for protecting the rights of human subjects are at least equivalent to those in the United States (Federal Regulation 46.101 (h)) and the substitution of those procedures may be approved. In other cases, the OPRR may require that the investigator establish a special HSRB in the foreign country to review the proposed research or take other steps to ensure that human subjects receive the same protection they would in the United States and that any special cultural factors are taken into consideration. For further information about conducting human subjects research in foreign countries, contact the Executive Secretary of the HSRB.